Pivotal Study for the FLAIR Endovascular Stent Graft

Inclusion Criteria: * Male or female patients between 18 to 90 years of age whose hemodialysis access was a synthetic AV access graft located in an arm. * Angiographic evidence of one or more stenoses, 7 cm or less in length and greater than or equal to 50%, at the graft-vein anastomosis of a synthetic AV access graft. The entire lesion must have been located within 7 cm of the anastomosis such that approximately 1 cm of the IMPRA/Bard Device must have extended into non-diseased vein and approximately 1 cm, but no more than 2 cm, of the IMPRA/Bard Device will be extended into non-diseased AV graft. * Clinical evidence of a hemodynamically significant stenosis. * Percutaneous endovascular therapy for the identified lesion was the best treatment choice in the opinion of the investigator. * Patients must have been able to understand and provide informed consent. * Patients whose synthetic AV access grafts had been implanted greater than 30 days and had undergone 1 or more successful hemodialysis sessions. * During primary balloon angioplasty, full expansion of an appropriately sized angioplasty balloon, in the operator's judgment, must have been achieved. Exclusion Criteria: * Concomitant disease (e.g., terminal cancer) or other medical condition that was likely to result in death of the patient within 6 months of the time of implantation. * Stenoses that had a corresponding thrombosis treated within 7 days. * The presence of a second lesion in the access circuit less than or…